Benev Sylfirm X
RF Microneedling · Dual-wave (CW+pulsed) bipolar RF microneedling
Technology: RF Microneedling
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New price
- $30k–$50kReported source: Dealer quote · Aug 12, 2026
- Used asking price
- $12k–$25kReported source: Used listing · Aug 12, 2026
- FDA status
- Supplies & recurring costs
- See supply and replacement costs below.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- Used asking prices
- 1 listing, latest Aug 12, 2026Used listing · Aug 12, 2026
- This panel shows a per-treatment supply cost only when a recorded figure has a dated source.
- Bottle prices and estimates may still appear under Treatment & running costs.
- The calculator may include a labeled planning estimate. Review it or enter your own allowance; missing data never means $0.
Figures are reference points, not current offers. Used asking prices are not completed-sale values.
Latest price source dated: Aug 12, 2026
·FDA database · Updated Aug 12, 2026Read FDA-cleared indicationsExact wording from 2 FDA records
K200185 (VIOL Co., Ltd., 2020)
The SYLFIRM X™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K213612 (VIOL Co., Ltd., 2022)
The SYLFIRM XrM is intended for use in dermatologic procedures for electrocoagulation and hemostasis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 4, 2026 · How we verify
Axis runs $0–$50k. Reference figures, not current offers. Used asking prices are not completed-sale values.
Not verified
We hold no per-treatment consumable price for this device from a dated source. Ask the seller for a written per-treatment cost.
Price sourcesSources, dates and configurations
Key factsCompany, specifications and verification dates
| Manufacturer | Benev (mfg Viol) |
|---|---|
| Company | Not published |
| Parent company | BENEV Company |
| Brand owner | Benev |
| Built by (OEM) | Viol Co., Ltd. |
| Category | RF Microneedling |
| Technology | Dual-wave (CW+pulsed) bipolar RF microneedling |
| FDA status | FDA Cleared |
| 510(k) citation | K200185, K213612 |
| New price range | $30k–$50k |
| Used asking range | $12k–$25k |
| Consumables | Not published |
| Launch year | 2021 |
| Latest price source dated | Aug 12, 2026 |
| Manufacturer-source documents checked | Not published |
Overview
Pulsed mode marketed for melasma/redness
How it worksTechnology and manufacturing
How the technology works
2MHz bipolar RF through a 25-pin microneedle array in two waveforms: continuous wave (CW) for conventional dermal heating, tightening, and scar remodeling, and ultra-short pulsed wave (PW) — the signature.
Pulsed delivery is claimed to selectively affect abnormal vessels and the dermal-epidermal junction while sparing normal tissue: the mechanistic basis for treating melasma, rosacea, and post-inflammatory redness, where continuous heating can worsen pigment.
Depth adjusts ~0.3-4.0mm; eight preset mode combinations cover wrinkles, scars, laxity, pigment, vascular concerns across all skin types.
Patented technology
The dual-wave (pulsed + continuous) RF delivery is the proprietary core — VIOL markets it as the first RF-MN system with both waveforms. In practice, a waveform-switching capability that changes how thermal energy accumulates — not different physics.
Origin
VIOL Co., Ltd., South Korea; Benev (Mission Viejo, CA) is exclusive US distributor.
FDA & regulatory detailClearance timeline, authorization route and citation notes
Source and verification notes
·FDA database · Updated Aug 12, 2026Clearance K200185; K213612FDA-cleared indications (verbatim)
K200185 (VIOL Co., Ltd., 2020)
The SYLFIRM X™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K213612 (VIOL Co., Ltd., 2022)
The SYLFIRM XrM is intended for use in dermatologic procedures for electrocoagulation and hemostasis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
RF Microneedling — Dual-wave (CW+pulsed) bipolar RF microneedling
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: BENEV Company
Legal manufacturer: Viol Co., Ltd. (South Korea)
Applicant on the FDA record
VIOL Co., Ltd.The applicant named on the FDA record can differ from the brand shown on the device.
Regulatory data comes from public FDA records and may lag recent updates. Confirm the applicable status and documentation before purchase.
FDA safety actions
Recorded recalls, warning letters and safety communications. Terminated actions remain visible as history.
How we report safety actionsChecked 7 Sep 2026 against FDA enforcement data dated 2 Sep 2026.
- FDA safety communicationFDA safety communication, issued 15 October 2025Open
Initiated Oct 15, 2025
Scope as FDA lists it
Applies to RF microneedling devices used for dermatologic or aesthetic procedures intended to improve the appearance of the skin. FDA is aware of reports of burns, scarring, fat loss, disfigurement and nerve damage, and of injuries needing surgical repair.
FDA advises providers to discuss these risks with patients and to report complications.
Reason and action
FDA advises providers to discuss these risks with patients before treatment, to use devices only as cleared, and to report complications to MedWatch. FDA did not name individual brands; the communication covers 510(k)-cleared RF microneedling devices as a class.
This communication applies to a class of devices, not to a specific unit or recall.
This is an FDA communication about a device class, not a recall of specific units; read the FDA notice for the reported risks and FDA's recommendations.
Manufacturer response: none on file — manufacturers can reply via their company profile.
FDA record
Look-alike devices
Comparing an unbranded RF microneedling unit? Check the exact model rather than relying on similar photos or treatment claims.
Listed manufacturer for this profile: Viol Co., Ltd.
- FDA record: Match any claimed 510(k) or De Novo number to the exact model and applicant in the FDA database.
- Support: Get written warranty, training, consumables and service terms from the seller.
- Financing: Confirm availability for the exact unit before including it in your budget.
We do not profile these unbranded units or verify their support and financing terms. This profile’s FDA record applies to the named device, not every similar-looking unit.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
Supply pricing is not documented with a dated source yet. Request an itemized supply quote.
Annual service & support
No annual service cost documented yet.
Payback calculatorModel your own volume, labor and service costs
Estimate your payback
Pre-filled from our published Benev Sylfirm X data where we have it. Estimates appear once the required inputs are available. Review and adjust every pre-filled value before relying on the result.
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Your estimate
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This model ignores financing — if you lease or borrow, add your monthly payment. Estimates from your inputs and our published ranges — not a projection, guarantee or financial advice. How we calculate this.
ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
Implanted electronic devices, pregnancy, active infection or open lesions, recent isotretinoin, keloid tendency, uncontrolled diabetes or healing disorders. Melasma patients need realistic expectations and strict photoprotection — it improves, it doesn't cure.
Warranty & serviceWhat to confirm in writing before you buy
Before buying new or used, confirm in writing:
- Current warranty coverage
- Included training
- Service terms
Chains using this device
A chain listing does not establish availability at every location.
No confirmed chain deployments recorded yet.
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
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History2 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 4, 2026
consumables detail
Manufacturer-conduct language removed or restated as a dated, sourced fact.
Source: Editorial sweep 2026-09-04: manufacturer-conduct language neutralized
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Benev Sylfirm X — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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